Preterm Infants: Light Effects on Health and Development

Duke University

Status: Completed

Conditions: Preterm Infant Health; Preterm Infant Development

Treatments: Other: Cycled Light

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02146287

R01NR008044 (U.S. NIH Grant/Contract)

Pro00011520

Details and patient eligibility

About

Preterm babies cared for in the intensive care nursery are exposed to amounts of light that are very different from the exposures to an unborn baby or the newborn term baby. Currently many nurseries try to protect premature babies from too much light. They may also try to create light conditions of day and night like many parent homes. Some studies have shown improvements in health and development of babies cared for in nurseries that try to change light for premature babies.

Enrollment: 121 patients

Sex: All

Ages: 23 to 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants were < 7 days of age and were born at 28 weeks or < 28 weeks

Exclusion criteria

• known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups

Early Cycled Light

Active Comparator group

Description:

Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA

Treatment:

Other: Cycled Light

Late Cycled Light

Active Comparator group

Description:

Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA

Treatment:

Other: Cycled Light